#### § 558.680 Zoalene.

(a) *Specifications.* Type A medicated article containing 25 percent zoalene.

(b) *Sponsors.* See Nos. 054771 and 058198 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)).

(c) *Related tolerances.* See [§ 556.770 of this chapter](/on/2024-09-23/title-21/section-556.770).

(d) *Conditions of use* —

(1) *Chickens* —

| Zoalene in grams/ton | Combination in grams per ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 36.3 to 113.5 | | Replacement chickens: For development of active immunity to coccidiosis | Feed continuously as sole ration. Grower ration not to be fed to birds over 14 weeks of age. Starter ration not to be fed to laying birds | 054771 058198 |

| Growing conditions | Starter ration Grams per ton | Grower ration Grams per ton |
| --- | --- | --- |
| Severe exposure | 113.5 (0.0125%) | 75.4-113.5 (0.0083%-0.0125%) |
| Light to moderate exposure | 75.4-113.5 (0.0083%-0.0125%) | 36.3-75.4 (0.004%-0.0083%) |

| Zoalene in grams/ton | Combination in grams per ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (ii) 36.3-113.5 | Bacitracin methylenedisalicylate 4 to 50 | Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency | Feed continuously as sole ration as in subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 054771 |
| (iii) 36.3 to 113.5 | Bacitracin methylenedisalicylate, 50 | Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by *Clostridium* spp. or other organisms susceptible to bacitracin | Feed continuously as the sole ration as in the subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 054771 058198 |
| (iv) 36.3 to 113.5 | Bacitracin methylenedisalicylate, 100 to 200 | Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by *Clostridium* spp. or other organisms susceptible to bacitracin | Feed continuously as sole ration as in the subtable in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 054771 058198 |
| (v) 113.5 | | Broiler chickens: For prevention and control of coccidiosis | Feed continuously as sole ration. Not to be fed to laying birds | 054771 058198 |
| (vi) 113.5 | Bacitracin methylenedisalicylate 4 to 50 | Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency | Feed continuously as sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 054771 |
| (vii) 113.5 | Bacitracin methylenedisalicylate, 50 | Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by *Clostridium* spp. or other organisms susceptible to bacitracin | Feed continuously as the sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 054771 058198 |
| (viii) 113.5 | Bacitracin methylenedisalicylate, 100 to 200 | Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by *Clostridium* spp. or other organisms susceptible to bacitracin | Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 054771 058198 |
| (ix) 113.5 | Bambermycins 1 | Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency | Feed continuously as sole ration. Do not feed to chickens over 14 weeks of age. Bambermycins as provided by No. 016592 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 016592 |

(2) *Turkeys* —

| Zoalene in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 113.5 to 170.3 | | Growing turkeys: For prevention and control of coccidiosis | Feed continuously as sole ration. For turkeys grown for meat purposes only. Not to be fed to laying birds | 054771 058198 |
| (ii) 113.5 to 170.3 | Bacitracin methylenedisalicylate, 4 to 50 | Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency | Feed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat purposes only. Not to be fed to laying birds | 054771 058198 |

(3) Zoalene may also be used in combination with:

(i)-(ii) [Reserved]

(iii) Lincomycin as in [§ 558.325](/on/2024-09-23/title-21/section-558.325).

[[41 FR 11005](https://www.federalregister.gov/citation/41-FR-11005), Mar. 15, 1976, as amended at [42 FR 18618](https://www.federalregister.gov/citation/42-FR-18618), Apr. 8, 1977; [42 FR 20817](https://www.federalregister.gov/citation/42-FR-20817), Apr. 22, 1977; [42 FR 36995](https://www.federalregister.gov/citation/42-FR-36995), July 19, 1977; [51 FR 7401](https://www.federalregister.gov/citation/51-FR-7401), Mar. 3, 1986; [52 FR 2686](https://www.federalregister.gov/citation/52-FR-2686), Jan. 26, 1987; [55 FR 8461](https://www.federalregister.gov/citation/55-FR-8461), Mar. 8, 1990; [57 FR 8403](https://www.federalregister.gov/citation/57-FR-8403), Mar. 10, 1992; [57 FR 8578](https://www.federalregister.gov/citation/57-FR-8578), Mar. 11, 1992; [61 FR 35957](https://www.federalregister.gov/citation/61-FR-35957), July 9, 1996; [63 FR 38750](https://www.federalregister.gov/citation/63-FR-38750), July 20, 1998; [67 FR 6868](https://www.federalregister.gov/citation/67-FR-6868), Feb. 14, 2002; [71 FR 16223](https://www.federalregister.gov/citation/71-FR-16223), Mar. 31, 2006; [71 FR 27958](https://www.federalregister.gov/citation/71-FR-27958), May 15, 2006; [76 FR 17027](https://www.federalregister.gov/citation/76-FR-17027), Mar. 28, 2011; [79 FR 10983](https://www.federalregister.gov/citation/79-FR-10983), Feb. 27, 2014; [79 FR 13546](https://www.federalregister.gov/citation/79-FR-13546), Mar. 11, 2014; [81 FR 17610](https://www.federalregister.gov/citation/81-FR-17610), Mar. 30, 2016; [81 FR 95025](https://www.federalregister.gov/citation/81-FR-95025), Dec. 27, 2016; [82 FR 21693](https://www.federalregister.gov/citation/82-FR-21693), May 10, 2017; [86 FR 14827](https://www.federalregister.gov/citation/86-FR-14827), Mar. 19, 2021; [87 FR 17948](https://www.federalregister.gov/citation/87-FR-17948), Mar. 29, 2022]